Protocol summary
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Study aim
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Determining the effect of self-care education on knowledge, attitude and quality of life in asthmatic patients
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Design
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A randomized, controlled clinical trial of 104 patients
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Settings and conduct
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The purpose of this study was to determine the effect of self-care education on knowledge, attitude and quality of life of asthmatic patients referred to Shahid Beheshti hospital of Hamedan University of Medical Sciences. The number of samples in this study is 104 patients. In this study, patients were randomly divided into two groups of intervention and control. In the intervention group, educational intervention will be performed in 4 sessions, but in the control group, except for routine care, no action will be taken. 8 weeks after the end of the intervention, the questionnaires will be completed by the two groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Age between 20 and 65 years, Suffering from asthma, Not having other chronic diseasesa
Exclusion criteria: Exit for any reason during the study, such as death, dissatisfaction to continue participating in the study
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Intervention groups
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In the intervention group, self-care education will be given in four sessions.The first session includes anatomy and physiology training, the second session includes how to adhere to the proper diet, how to adhere to the prescribed regimen, the third session includes daily activities, exercise, stress-avoidance education. The fourth session involves training skills such as the use of respiratory sprays. Then, 8 weeks after the completion of the interventions, the questionnaires are given to two groups.
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Main outcome variables
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Quality of life
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160110025929N7
Registration date:
2018-02-06, 1396/11/17
Registration timing:
prospective
Last update:
2018-02-23, 1396/12/04
Update count:
1
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Registration date
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2018-02-06, 1396/11/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-02-09, 1396/11/20
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Expected recruitment end date
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2019-02-09, 1397/11/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The impact of self-care education on awareness, attitude and quality of life in patients with asthm referred Shahid Beheshti hospital to clinic of Hamedan university of medical sciences
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Public title
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Impact of self-care education on awareness, attitude and quality of life in patients with asthma
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age between 20 and 65 years
Suffering from asthma
Not having other chronic diseases
Exclusion criteria:
Dissatisfaction to continue participating in the study
Exit for any reason during the study, such as death
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Age
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From 20 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
104
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomly,104 patients are selected. Then, using random blocks, they will be divided equally in to two groups of intervention and control
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-01-13, 1396/10/23
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Ethics committee reference number
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IR.UMSHA.REC.1396.725
Health conditions studied
1
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Description of health condition studied
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Asthma
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ICD-10 code
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J45
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ICD-10 code description
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Asthma
Primary outcomes
1
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Description
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Quality of life
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Timepoint
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Before anf after intervention
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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Intervention group: Self-care education will be given in four sessions.The first session includes anatomy and physiology training, the second session includes how to adhere to the proper diet, how to adhere to the prescribed regimen, the third session includes daily activities, exercise, stress-avoidance education. The fourth session involves training skills such as the use of respiratory sprays
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Category
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Lifestyle
2
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Description
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Control group: Except for routine care, no action will be taken.
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Category
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Lifestyle
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Hamedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available